DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Receipt is acknowledged for preliminary amendment filed 09/12/2023 and IDS filed 08/28/2025.
Claims 1, 4-8, 10-13 and 15 are amended.
Claim 14 is canceled.
Claims 1-13 and 15 are pending.
Priority
This applicant claims benefit of EPO application 22 195 467.0 filed 09/13/2022.
Information Disclosure Statement
The IDS filed 08/28/2025 has been considered by the examiner.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fiorica et al., “Hyaluronic acid and a-elastin based hydrogel for three dimensional culture of vascular endothelial cells” in Journal of Drug Delivery Science and Technology, 46 (2018) 28-33.
Claim 15 is an article that comprises hydrogel comprising water soluble elastin derivative.
Fiorica discloses scaffold that comprises hyaluronic acid comprising copolymer of hyaluronic acid and a-elastin (see the whole document with emphasis on the abstract, Section 2). Fiorica teaches that a-elastin is a water soluble fraction of elastin (line 2 of left column of page 29). The comprising language of the claim is open.
The teaching of Fiorica anticipates claim 15.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over ORR et al. (WO 2021191897 A1) in view of or as evidenced by Tian et al., “In-situ formed elastin-based hydrogels enhance wound healing via promoting innate immune cells recruitment and angiogenesis” in Materials Today Bio, available online May 21, 2022.
ORR et al. (WO 2021191897 A1) discloses a process for bioprinting 3D article, such as breast implant, from a composition comprising ECM component comprising hyaluronic acid, fibronectin, heparin, modified elastin (methacrylated or thiolated elastin) or elastin or laminin or any combination elastin (Figure 7, page 8, lines 26-28; page 9, lined 4-6; page 10, lines 25-28; page 17, lines 10-15; page 35, line 13; paragraph bridging pages 54 and 55; page 59, lines 5-8; page 65, lines 24-24; page 72, lines 9-11; page 73, lines 2-5, 27-29; page 74, lines 11-13, 24-25; page 78, lines 19-26, 34). The technologies developed for 3D printing include extrusion printing, laser assisted printing and projection stereolithography (page 4, lines 51-52; page 5, lines 23-24; claims 18, 23. 40) and the process of 3D scaffold manufacturing process includes extrusion printing/printer (page 34, line 12; page 43, lines 15-30). When elastin derivative such as modified elastin is 3D printed into hydrogel to produce 3D printed hydrogel article by extrusion, the limitation of providing elastin derivative is met.
Thus for claim 1, ORR teaches all the elements of the claim except that ORR does not say that the thiolated elastin or the methacrylated elastin in water soluble. However, methacrylated elastin is water soluble as evidenced by Tian ( see the whole document with emphasis on the abstract, second full paragraph, left column of page 2, section 2). Therefore, before the effective date of the invention, the artisan would reasonably expect that the modified elastin of ORR is predictably water soluble.
For claims 2-4 the hydrogel of ORR further comprises hyaluronic acid (see the whole document with emphasis on at least claims 18, 23 and 40) which is a polysaccharide of natural origin.
For claim 5, the hydrogel of ORR contains biocompatible synthetic polymer namely polylactic acid (PLA), polyglycolic acid (PGA), polycaprolactone (PCL), poly (lactic-co-glycolic acid) (PLGA), polyethylene glycol (PEG), polyvinyl alcohol (PVA), poly(N-isopropylacrylamide) (PNIPAAm), poly-4-hydroxybutyrate (P4HB) or any copolymer thereof (page 8, lines 12-16; page 52, lines 18-22).
For claim 6, Tian teaches that elastin can be hydrolyzed via visible light crosslinking (right column, page 11, first full paragraph; left column of page 2, second full paragraph).
For claims 7 and 8, ORR teaches modification of the elastin to form water soluble elastin (see page 55, line 13) and Tian teaches preparation of soluble elastin (section 2).
For claim 9, the thiolated and methacrylate elastin has function -SH and -C=O groups.
For claims 10-12, ORR teaches crosslinking step (page 59, line 9) and Tian also teaches crosslinking using visible light crosslinking (page 2, second full paragraph left column and first full paragraph, right column).
ORR in combination with Tian has been described above to render claims 1-12 prima facie obvious.
Claim(s) 1, 7, 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over ORR et al. (WO 2021191897 A1) in view of or as evidenced by Tian et al., “In-situ formed elastin-based hydrogels enhance wound healing via promoting innate immune cells recruitment and angiogenesis” in Materials Today Bio, available online May 21, 2022, and further in view of Majima et al., “Phenyl-2,4,6-trimethylbenzoylphosphinates as water-soluble photoinitiators. Generation and reactivity of O=P(C6H5)(O-) radical anions” in Makromol. Chem. 192, 2307-2315 (1991).
Claims 1, 7 and 12 have been described above as being prima facie obvious over ORR in combination with Tian.
Claim 7 depends on claim 1; claim 12 depends on claim 7.
Claim 13 depends on claim 12.
The process of ORR in combination with Tian does not teach the photo-initiators of claim 13. However, it is known tin the art that Lithium Phenyl-2,4,6-trimethylbenzoylphosphinates are effective water soluble photo-initiators (see at least the summary in Majima). Therefore, before the effective date of the invention, the artisan would be motivated to use the photo-initiators such as Lithium Phenyl-2,4,6-trimethylbenzoylphosphinate with the expectation that the photo-initiator would predictably convert absorbed light energy into chemical energy in the form of initiating species.
Therefore, ORR in combination with Tian and in view of Majima renders claim 13 prima facie obvious.
No claim is allowed.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613